What Do Risk-Based Monitoring and Patient Engagement Have in Common?

May 16, 2013
Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at lhenderson@mmhgroup.com.

Applied Clinical Trials

This year, CBI will be co-locating their Risk-Based Monitoring in Clinical Studies conference and Clinical Patient Engagement Summit this October 24-25, 2013 in Philadelphia.

SPOTLIGHT EVENTRisk-Based Monitoring – Beyond Theory In-Depth ReviewMarch 13, 2014
Cambridge, MassachusettsDownload BrochureRegister

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What Do Risk-Based Monitoring and Patient Engagement Have in Common?

In this context, co-location.

Last week, I had a call with two conference producers at our sister organization CBI. The conferences are in development for October 24 and 25 and are co-located in Philly. The topics are of very high interest to those in clinical operations, and the rest of the industry, right now.

Risk-Based Monitoring
Can we not get enough of risk-based monitoring? No. Ever since the FDA put out the draft guidance in August 2011talk of RBM has escalated. While many clin ops executives were talking about RBM, last year, (view here, scroll to bottom videos) they were in the gathering of information and insight mode. And once the fact gathering was over, action was required …we think from the top-down…to get this cost saving, more efficient strategy in place. But there are many layers to RBM and they are not one-size-fits-all. Technologies to support risk-based monitoring strategies, lead to implementation, lead to discussion of centralization, lead to talk of roles and changing roles, lead to operational changes…you cannot have one discussion without the other in developing a risk-based monitoring strategy.

We have a number of articles about risk-based monitoring, most news, but other peer-reviewed and some in the queue for publication. The conference will also offer a chance for you to join the discussion in person and network. So consider registering and I will you keep you posted on the progress.


Patient Engagement
The Clinical Patient Engagement Summit takes over where the Patient Centricity in Clinical Trials conference left off in January 2012. For that conference, the producer brought together a very dynamic group of interested speakers and attendees. They described different strategies and aspects of engaging patients in clinical trials. This can go from recruitment, to retention, to protocol design, to ePRO, virtual trials…everywhere the patient can be touched and encouraged in a trial.

This year’s agenda is shaping up to be just as compelling. And not because I’m Chairperson. This topic continues to be an interesting and necessary conversation in the industry.

Currently, these topics are on tap, but please feel free to email [email protected] me an idea you would like to hear about.   

  • Clinical study planning and modeling through patient centric initiatives

  • Social media and mobile platforms for added efficiency in clinical trials

  • Direct-to-patient channels for identifying, recruiting and retaining trial participants

  • Strategies to improve clinical data and ePRO collection

  • Collaborative and communication across trial sponsors, CRO’s, sites and patients


More articles on patient engagement:

Patient-First Approach to Improve Oncology Clinical TrialsThe Personal Touch in Patient InformationTrying New Patient Solutions Strategies

More articles on risk-based monitoring:

Risk-Based Monitoring: An Opportunity to go Back to BasicsRisk-Based Monitoring: A Primer for Small to Mid-Size SponsorsRisk-Based Monitoring Risky for Sponsors?Has the 2011 FDA Guidance on Risk-Based Monitoring Impacted SDV Coverage Yet?Targeting Source Document Verification

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